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Administrative and Bioinformatics
Coordinating Center (ABCC)
City of Hope National Medical Center
Division of Information Sciences
1500 East Duarte Road
Duarte, CA 91010-3000 |
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Grant No. 1 U42 RR17673-01 |
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Application for Clinical Grade Islets for
Transplantation |
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Completed Application
for ICR Services: Clinical Transplantation
must be received by February 15 and September 1.
The ICR Steering Committee will review, assign priority
scores, and rank applications based on the scientific
merit and feasibility of the proposal, including:
(1) the clinical and pre-clinical data leading to
the proposed clinical trial, (2) the suitability
and technical feasibility of the proposed approach,
(3) the capacity of the investigator to enroll patients
in the proposed study, (4) the availability of the
required clinical and laboratory support, (5) the
planned statistical evaluations of the clinical
and laboratory endpoints, (6) the technical, legal,
and ethical issues of the proposed protocol, (7)
the likelihood of success for the proposed approach
in relationship to other clinical trials, (8) the
resources required for the proposed trial, including
sources of funding for safety testing, clinical
studies, data management, and post therapy laboratory
and clinical evaluations, (9) the current status
of the proposed protocol, (10) efforts to ensure
that NIH guidelines for patient safety, and minority
and gender representation in the clinical trial
are satisfied, and (11) ICR support available for
the project. |
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Application for Islets for Basic Research |
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All investigators requesting islets must download
the Application
for ICR Services: Basic Science Islets, complete
the form, and submit it to the Administrative and
Bioinformatics Coordinating Center (ABCC) of the
ICRs by surface mail. In addition to the completed
application form, applicants must also submit a
concise but thorough and informative description
of the specific objectives, methods associated with
the use of islets, rationale for the number of islets
requested and statistical methodologies to be employed.
If the islets are to be used for a project supported
by a NIH funded or other peer reviewed grant, this
should be noted and appropriate information (i.e.
specific aims, etc.) provided. Provision of adequate
information for review will enhance the applicant’s
application. |
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A
subcommittee of the ICR Steering Committee consisting
of two ICR investigators and one non-ICR will review
the applications on a monthly basis and will make
recommendations based on the information submitted.
All applicants will be notified of approval or disapproval.
If approved, applicants may then arrange for subsequent
receipt of islets from a specific ICR. |
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Inquiries |
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For resource information, contact Janice Sowinski (see
below). |
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For programmatic information, contact: |
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Daniel Rosenblum, M.D.
Division of Clinical Research
National Center for Research Resources
1 Democracy Plaze Room 915
Bethesda, MD 20892
Phone: 301-435-4051
Fax: 301-480-3661
E-mail: rosenblumd@mail.nih.gov
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Key ABCC Staff Members |
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Director
Joyce Niland, Ph.D.
626-256-4673 x63032; Fax: 626-301-8802
E-mail: jniland@coh.org
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ABCC Co-Director for Biomedical Informatics
Douglas Stahl, Ph.D., M.B.A.
626-256-4673 x65616; Fax: 626-256-8727
E-mail: dstahl@coh.org
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Project Administrator
Janice Sowinski, M.S..
626-256-4673 x61260; Fax: 626-930-5440
E-mail: jsowinski@coh.org
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Consortium Resources |
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Special Services, Facilities, or Instruments
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- Islet Cell Resource Centers: Generate human
islet cells and perform relevant tests in facilities
compliant with Good Manufacturing Practice (GMP)/Good
Laboratory Practice (GLP) guidelines.
- ABCC: Administrates the Consortium, acquires
data, and performs biostatistical reviews to
meet ICR goals.
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